ETSense: Adaptive Portable Essential Tremor Monitor

描述（由申请人提供）：目的是设计、实施和临床评估“ETSense”，一种自适应、紧凑、便携式特发性震颤（ET）监测仪，用于优化治疗干预。在美国，ET影响大约4%的40岁以上的人群，并且主要特征在于肢体的姿势性和运动性（动作）震颤，其通过各种主观震颤评定量表（TRS）评定。这些量表都在离散的时间点提供离散的主观症状评级，需要临床医生对患者进行目视评估，并且无法捕获全天响应于干预而发生的复杂波动。在日常活动中持续客观地捕获ET症状，并使用自适应算法对震颤类型和严重程度进行分类，将有助于临床医生更好地滴定治疗，以最大限度地减少症状波动，并将护理扩展到农村和服务不足的人群。CleveMed此前开发了一种紧凑的无线系统，用于量化帕金森病（PD）症状，称为ParkinSense。在临床研究中，该系统成功地证明了PD运动症状的客观量化。PD的有希望的结果表明，该系统可以通过开发特定的ET算法和更连续的便携式监测来量化ET患者的震颤，以捕获全天可能发生的震颤波动。所提出的系统的主要创新将是用于在日常生活活动期间连续监测的紧凑的便携式用户穿戴硬件，以及用于连续分类震颤类型和频率严重性的智能自适应算法。包括加速度计和陀螺仪的组合将提供一种系统，该系统对于震颤类型辨别和严重性评级具有比当前现有的单轴系统大得多的灵敏度。最终的系统将包含在一个轻量级的手指佩戴式外壳中，不需要PC，可以在家中或公共场合连续佩戴。器械将检测运动（震颤或自主），以开始数据收集。设备上的按钮将允许患者指示何时服用药物。所有数据将存储在内存中，用于后续分析和报告生成，详细说明治疗干预后的症状波动。ETSense将为ET症状的持续评估提供标准化平台。便携式设计将允许患者在家中，工作场所或公共场所执行日常任务，同时存储震颤类型和严重程度。临床报告将详细描述症状波动，以优化治疗干预和开发新的治疗方案。公共卫生相关性：特发性震颤，主要特征是运动期间的震颤，影响美国40岁以上人口的约4%。临床检查期间存在各种震颤评级量表，用于主观评级震颤严重程度。拟议的ETSense自适应便携式特发性震颤监测仪将在患者进行典型活动时对震颤类型进行分类，并在一天中连续评级震颤严重程度，这将有助于临床医生更好地制定治疗方案，并有助于开发新的治疗干预措施。

DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess ETSense", an adaptive, compact, portable essential tremor (ET) monitor for optimizing therapeutic interventions. ET affects approximately 4% of the population over age 40 in the United States and is characterized primarily by postural and kinetic (action) tremors of the limbs, which are rated by various subjective tremor rating scales (TRS). These scales all provide a discrete, subjective symptom rating at a discrete point in time, require a clinician to visually assess the patient, and cannot capture complex fluctuations that occur throughout the day in response to interventions. Objectively capturing ET symptoms continuously during daily activities and using adaptive algorithms to both classify tremor types and severity will help clinicians better titrate therapy to minimize symptom fluctuations and expand care to rural and underserved populations. CleveMed has previously developed a compact wireless system to quantify Parkinson's disease (PD) symptoms called ParkinSense". In a clinical study, this system successfully demonstrated objective quantification of PD motor symptoms. The promising results for PD suggest the system may be adapted for quantifying tremor in ET patients by developing specific ET algorithms and more continuous portable monitoring to capture the tremor fluctuations that can occur throughout the day. The primary innovation of the proposed system will be compact, portable user worn hardware for continuous monitoring during activities of daily living and intelligent, adaptive algorithms to continuously classify tremor type and rate severity. Including a combination of accelerometers and gyroscopes will provide a system with much greater sensitivity for tremor type discrimination and severity rating than currently existing uniaxial systems. The final system will be contained in a lightweight, finger-worn housing that does not require a PC and can be worn continuously at home or in public. The device will detect motion (tremor or voluntary) to begin data collection. A button on the device will allow the patient to indicate when medication is taken. All data will be stored in memory for subsequent analysis and report generation detailing symptom fluctuations in response to therapeutic interventions. ETSense will provide a standardized platform for continuous evaluation of ET symptoms. The portable design will allow patients to perform everyday tasks at home, at work, or in public while tremor type and severity is stored. Clinical reports will detail symptom fluctuations for optimizing therapeutic interventions and the development of novel treatment protocols. PUBLIC HEALTH RELEVANCE: Essential tremor, characterized primarily by tremor during movement, affects approximately 4% of the population over age 40 in the United States. Various tremor rating scales exist for subjectively rating tremor severity during a clinical exam. The proposed ETSense adaptive, portable essential tremor monitor will classify tremor type and rate tremor severity continuously throughout the day while a patient performs typical activities, which should help clinicians to better prescribe treatment and aid in the development of novel therapeutic interventions.